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Multiple MyelomaPhase 2/3NCT03759093

CURATE.AI Optimized Modulation for Multiple Myeloma

A Phase 2/3 study testing Bortezomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical trial applying CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, to Bortezomib, Thalidomide, Cyclophosphamide and Lenalidomide dosing in multiple myeloma patients to show improvement in response. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib, Cyclophosphamide and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSingapore
Study dates
10 Sep 2023to 10 Sep 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Multiple myeloma diagnosed according to standard criteria, without prior anti-myeloma treatment at study entry. Both transplant eligible and ineligible patients may be included.
  • Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
  • Serum M-protein ≥ 0.5g/dL, or
  • In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
  • Males and females ≥ 18 years of age or > country's legal age for adult consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Show all 11Show fewer
  • Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
  • Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
  • Calculated creatinine clearance ≥ 30mL/min or creatinine < 3mg/dL.
  • Written informed consent in accordance with federal, local and institutional guidelines

Who cannot join

  • Female patients who are lactating or pregnant
  • Multiple Myeloma of IgM subtype
  • Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
  • POEMS syndrome
  • Plasma cell leukaemia or circulating plasma cells ≥ 2 x 109/L
  • Waldenstrom's Macroglobulinaemia
Show all 24Show fewer
  • Patients with known amyloidosis
  • Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting bortezomib treatment
  • Focal radiation therapy within 7 days prior to start of treatment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of treatment
  • Immunotherapy (excluding steroids) 21 days prior to start of treatment
  • Major surgery (excluding kyphoplasty) within 28 days prior to start of treatment
  • Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
  • Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
  • Patients with known cirrhosis
  • Second malignancy within the past 3 years except:
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Breast carcinoma in situ with full surgical resection
  • Patients with myelodysplastic syndrome
  • Patients with steroid, cyclophosphamide, bortezomib, lenalidomide or thalidomide hypersensitivity
  • Patients with a calculated creatinine clearance less than 30ml/min by the Cockroft Galt method.
  • Prior treatment with Bortezomib
  • Contraindication to any of the required concomitant drugs or supportive treatments
  • Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol

Trial locations and contacts

1 site in 1 country.

Wee Joo Chng, Prof contact

67795555

mdccwj@nus.edu.sg

Sanjay de Mel, Dr contact

67795555

sanjay_widanalage@nuhs.edu.sg

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore, 119228

    Wee Joo Chng, Prof, 67795555, mdccwj@nus.edu.sg

    Sanjay de Mel, Dr, 67795555, sanjay_widanalage@nuhs.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Phenotypic Personalized Medicine: Systematically Optimized Combination Therapy in Multiple Myeloma Using CURATE.AI

Clinical trial applying CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, to Bortezomib, Thalidomide, Cyclophosphamide and Lenalidomide dosing in multiple myeloma patients to show improvement in response.

Read the detailed description

In conventional combination chemotherapy, drug doses are typically determined using dose escalation to reach a maximum tolerated dose (MTD) or via dose expansion to identify suitable regimen administration guideline, and the combinations are subsequently administered at fixed doses. During the course of treatment, the patient's response to therapy evolves and changes due to the time-dependent, dose dependent, and patient-specific nature of drug synergy and resulting efficacy and tolerability. To overcome this challenge, we have developed CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, which has been clinically validated and used to prospectively optimize patient liver transplant immunosuppression, and tuberculosis therapy, among other indications. In this study, CURATE.AI may improve patient response by providing dose recommendations for Bortezomib, Thalidomide, Cyclophosphamide and Lenalidomide to the clinical team over the course of the patient's treatment.

Being tested
Bortezomib, Cyclophosphamide, Dexamethasone, CURATE.AI-Guided dosage modulation, Thalidomide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Also called Velcade

    Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

  • CyclophosphamideDrug

    Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

  • DexamethasoneDrug

    Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

  • CURATE.AI-Guided dosage modulationOther

    CURATE.AI-guided modulation of Velcade and Cyclophosphamide dosages for VCD regimen, Velcade and Thalidomide dosages for VTD regimen, and Velcade and Lenalidomide dosages for VRD regimen

  • ThalidomideDrug

    Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

  • BortezomibDrug

    Also called Velcade

    Dose in a range of 0.7,1.0,1.3 mg/m2 subcutaneous (SC) injection on Day 1, 8, 15 ,22 for cycles 1 to 4 , as determined and guided by CURATE.AI and approved by the clinical care team

  • CyclophosphamideDrug

    Dosing in a range of 100, 300, 500 mg PO on Day 1, 8, 15, 22 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.

  • ThalidomideDrug

    Dose in a range of 50-200mg PO on day 1-28 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.

  • DexamethasoneDrug

    40 mg PO on Day 1 ,8 , 15, 22 for cycles 1 to 4, as determined and guided by the clinical care team according to standard of care

  • LenalidomideDrug

    Also called Revlimid

    Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

  • LenalidomideDrug

    Also called Revlimid

    Dose in a range of 5-25mg PO on day 1-21 for cycles 1 to 4, as determined and guided by CURATE.AI and approved by the clinical care team.

Study groups in NCT03759093
Study groupRoleWhat they receive
Standard of CareActive comparatorDosing of VCD(bortezomib, cyclophosphamide,dexamethasone), VTD (bortezomib,thalidomide, dexamethasone), or VRD (Bortezomib, Lenalidomide, Dexamethasone) combinations according to standard of care
Receives: Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Thalidomide; Drug: Lenalidomide
CURATE.AI-guided dosingExperimentalCURATE.AI optimized modulation of bortezomib and cyclophosphamide dosages in the VCD (bortezomib, cyclophosphamide, dexamethasone), bortezomib and thalidomide in the VTD (bortezomib, thalidomide, dexamethasone) or bortezomib and lenalidomide in the VRD (bortezomib, lenalidomide, dexamethasone) combinations
Receives: Other: CURATE.AI-Guided dosage modulation; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Thalidomide; Drug: Dexamethasone; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Complete response (CR), or stringent complete response (sCR), or very good partial response (VGPR), or partial response (PR) based on IMWG criteria at the end of cycle 4

    Measured: Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)

Secondary outcomes (1)

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria.

    Measured: Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2018
  2. Study start10 Sep 2023 (estimated)
  3. Primary completion10 Sep 2025 (estimated)
  4. Study completion10 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03759093
Sponsor's protocol ID
2015/00280
Other IDs
2015
Status last verified
Aug 2023
First submitted
20 Nov 2018
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pantuck, A.J., Lee, D.K., Kee, T., Wang, P., Lakhotia, S., Silverman, M.H., Mathis, C., Drakaki, A., Belldegrun, A.S., Ho, C.M. and Ho, D., 2018. Modulating BET Bromodomain Inhibitor ZEN-3694 and Enzalutamide Combination Dosing in a Metastatic Prostate Cancer Patient Using CURATE. AI, an Artificial Intelligence Platform. Advanced Therapeutics, 1(6), p.1800104.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bortezomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wee Joo Chng, Prof (67795555, mdccwj@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03759093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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CURATE.AI Optimized Modulation for Multiple Myeloma | AzTrials